Kornimate/medical-research-clean huggingface dataset:
sirolimus effect on hypertrophic syndromes related gene pik3ca

Conditions: Segmental Overgrowth Disorders Due to PIK3CA

Summary: it was found that people who have an excessive growth in one or more parts of their body and normal growth in other parts, may have a change in genes responsible for controlling cell growth. this genetic discovery identified a possible treatment for this overgrowth, called sirolimus. this is a pilot study, which help the investigators prepare a larger international study, which will aim to determine whether a treatment based sirolimus is able to stop the excessive growth of one or more parties of their body in people who carry a genetic change in the pik3ca gene (phosphatidylinosilol-3-kinase encoded by the gene pik3ca).

the duration of participation is 15 months: * visit screening: blood test, pre-clinical evaluation, urine collection and chest x-ray. * first 6 months: participants will have their overgrowth monitored. this step includes 2 visits taking place at the university hospital of dijon: complete clinical evaluation, mri of the body part by the overgrowth and dual-energy x-ray absorptiometry (dxa). * next 6 months: participants will take sirolimus. this step includes 2 visits (4 and 13 weeks after the start of treatment at local hospital): blood test, urine collection and clinical evaluation. and 1 end of study visit after 6 months of treatment taking place at the university hospital of dijon: blood test, complete clinical evaluation, urine collection, mri and dxa. participants will have several blood and urine tests between visits (1 and 2 weeks after the start of treatment at a local laboratory).

Eligibility criteria:
inclusion criteria: * post-zygotic pik3ca mutation * age: 3-65 years * measurable overgrowth, in current progression or with clinical history of overgrowth progression * patient clinically stable * presence of a disability, social or cosmetic impairment requiring treatment from the patient perspective, * written informed consent form signed and dated by the subject or by the patient's legal representative exclusion criteria: * pregnancy or lactation * women and men of reproductive age without any effective method of contraception (during treatment and up to 12 weeks after sirolimus discontinuation) * hypersensitivity to the active substance (sirolimus) or to any of the excipients * impossibility to obtain written informed consent form signed by the subject or the patient's legal representative, or vulnerable adults * treatment with sirolimus in the last 4 weeks before the trial * personal history of malignancy or current investigations for suspected malignancy * active skin infection requiring antibiotics or antiviral treatments * hiv or hepatitis b or c infection * past history of mycobacterium tuberculosis infection * active pneumopathy * uncontrolled infection * chronic liver disease (asat or alanine amino transférase (alat)\> 3 times upper normal limit) * stage 3 (or more) chronic renal insufficiency (egfr\< 60mls/min) * neutropenia with neutrophiles \< 1.0 x10\^9/l * uncontrolled dyslipidemia * inability to attend study visits
magnevist (sh l 451a) intra-individual dose comparison study in magnetic resonance angiography

Conditions: Magnetic Resonance Angiography; Peripheral Vascular Diseases; Peripheral Arterial Diseases

Summary: the objective of the study was to compare the efficacy of magnevist (sh l 451 a) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3d-magnetic resonance angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. magnevist (sh l 451 a) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. the safety of the 0.2 mmol/kg dose was also assessed.


Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo contrast-enhanced 3d-magnetic resonance angiography exclusion criteria: * patients with an ankle brachial pressure index (abpi) of 0.3 or less * patients with allergy to contrast media * patients with serious hepatic impairment * patients with serious renal impairment

Keywords: magnevist magnetic resonance angiography meglumine gadopentetate determination of effective dose in mra
tulip : role of the tumor environment in cancer-related fat loss

Conditions: Cancer; Cachexia; Adipose Tissue

Summary: cancer cachexia is defined as a weight loss of more than 5% over the last 6 months, a loss of body fat and muscle atrophy. it is found in 80% of patients with advanced cancer. in this context, white adipose tissue is a particularly interesting target since its depletion precedes the loss of muscle mass, and is sufficient to induce a decrease in the response to anti-cancer treatments and in the survival of patients. this cachexia is associated with advanced tumors that present acidosis and metastasis. in this clinical study the investigators would like explore the acid environment effect on the human adipose tissue depletion and more specifically on adipocyte lipolysis. the main objective of the "tulip" clinical study is therefore to validate in human subcutaneous and visceral adipocytes that factors secreted by tumor cells cultivated in acid tumor environment stimulate the release of lipids from adipose tissue. adipocytes retrieves from this study will also be used to validate identified potential lipolytic factors derived from these cells.

this study is a monocentric clinical study. patients with bmi \< 30 kg/m2 will be recruited in the context of programmed abdominal surgery. in this context, subcutaneous and visceral adipose tissue pieces (1-2 cm3) will be collected to explore the lypolytic response of adipocytes ex-vivo to factors secreted by human cancer cell lines.

Eligibility criteria:
inclusion criteria: * programmed surgeries in the abdominal area in the department of surgery and transplantation at cliniques universitaires saint-luc under the supervision of prof. dr. benoit navez. * hospitalization in the context of surgery * caucasian * age between 18 and 60 years (included). * body mass index less than 30 and greater than or equal to 18.5 * programmed nissen fundoplication (to treat hiatal hernia and gastroesophageal reflux) or cholecystectomy (to treat vesicular lithiasis), eventration, or parietal surgery . * adults capable of expressing their wishes. * understanding french exclusion criteria: * body mass index below 18.5 and above 30. * patients with cancer, infection, autoimmune or inflammatory disease, metabolic syndrome. * patients with beta-blockers, hypoglycemics, anti-diabetics, hypolipidemics. * adults unable to express their will. * not understanding french * patients participating in a clinical trial for a drug treatment.
prevention of renal and vascular endstage disease intervention trial

Conditions: Microalbuminuria; Cardiovascular Diseases; Renal Disease

Summary: the prevention of renal and vascular endstage disease intervention trial (prevend it) was designed to determine whether intervention with the angiotensin-converting enzyme (ace) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme a reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.

this study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/ day will prevent cardiovascular and renal disease in nonhypertensive (rr \ 10 mg/l once in an early morning spot urine and 15 to 300 mg/24-hour at least once in two 24-hour urine collections). the prevention of renal and vascular endstage disease intervention trial is a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design. the 864 randomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years. the primary efficacy parameter is defined as the combined incidence of all-cause mortality or hospital admission for documented (1) nonfatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease.

Eligibility criteria:
inclusion criteria: * persistent microalbuminuria (urinary albumin excretion \>10mg/l once in an early morning spot urine and 15 to 300 mg/24 hours at least once in two 24-hour urine samples) * no hypertension (rr \<160/100 mm hg, no anti-hypertensive medication) * no hypercholesterolemia (total cholesterol \<8.0 or \<5.0 mmol/l in case of previous myocardial infarction and not using lipid-lowering medication) exclusion criteria: * creatinine clearance \>60% of the normal age-adjusted value * serum potassium \>5.5 mmol/l * history of chronic liver disease * lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase \>3 times the upper limit of normal * use of angiotensin-converting enzyme inhibitors or angiotensin ii receptor antagonists * use of insulin * previously documented allergy or intolerance to study drugs * pregnant or nursing women
study of effects of dao-in exercise on the perimenopausal women with sleep disturbance

Conditions: Peri-menopausal Women; Sleep Disturbances; Dao-in Exercise; Body Constitution

Summary: among health problems of peri-menopausal women, sleep disturbances is very common complaint. the aim of this study is to realize the body constitution of the peri-menopausal women with sleep disturbance; and to evaluate the effects of duo-in practice on this population to see if this intervention can decrease the dosage of hormone replacement therapy. quasi-experimental design and convenient sampling are both adopted. participants will be recruited from china medical university, tri-service general hospital, taiwan society of health promotion, and dr. chen's obstetrics and gynecology clinic. one hundred of participants who are willing to try duo-in exercise to improve their sleep quality will be randomly assigned into experiment group and control group. the experiment group will practice duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the control group. then, after 2 weeks, the participants of experiment and control group will crossover. the experiment group has no intervention, but the control group will practice duo-in exercise for 2 months. chinese version of the pittsburgh sleep quality index (cpsqi), body constitution questionnaire (bcq), peri-menopausal disturbance scale, and peri-menopausal fatigue scale will be used in the assessment at each time point. according to previous experience, a total of 70 participants will completed the whole observation course. generalized estimating equations (gee) is applied to analyzed the repeated measurement of different time and groups. this study will provide the evidence for duo-in exercise as complementary treatment for hormone replacement therapy for peri-menopausal women, and also for integration of dao-in exercise into mainstream treatment for other patients with sleep disturbance.


Eligibility criteria:
inclusion criteria: * peri-menopausal women who have sleep disturbances. * peri-menopausal women who can walk freely and without any disable. exclusion criteria: * peri-menopausal women who have cancer and other life-threatening diseases. * peri-menopausal women who have psychological diseases.

Keywords: peri-menopausal women sleep disturbances dao-in exercise body constitution
peripheral central catheter (picc) care

Conditions: NEWBORN; Pain, Acute

Summary: peripheral central catheter (picc) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes. today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. this research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in picc care in preterm babies.


Eligibility criteria:
inclusion criteria: * without congenital defects, * not receiving sedation at least 3 hours before picc care, * no unexplained crying, * without neurological problems, * not undergoing surgical intervention, * babies with picc insertion exclusion criteria: * having had a painful procedure (invasive procedure, etc.) within the last hour, * babies for whom permission was not obtained from the parent through an informed voluntary consent form
telcagepant (mk-0974) treatment of migraine in participants with stable vascular disease (mk-0974-034)

Conditions: Migraine Disorders; Heart Disease; Cerebrovascular Accident; TIA (Transient Ischemic Attack); Vascular Diseases; Peripheral Vascular Diseases

Summary: the purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. acetaminophen/paracetamol (apap) will be used as an active comparator in this study. the primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.


Eligibility criteria:
inclusion criteria: * stable coronary artery disease for 3 months or more * 18 years of age or older with a history of migraine with or without aura * must use acceptable contraception throughout the study exclusion criteria: * pregnant, breast-feeding, or planning to become pregnant during this study * 50 years of age or older when migraines began * other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine) * history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
a study to evaluate the effect of famciclovir in reducing herpes virus shedding

Conditions: Genital Herpes

Summary: the study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (hsv-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (hsv-1) seropositivity.


Eligibility criteria:
inclusion criteria: * males or non-pregnant females at least 18 years of age with hsv-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes exclusion criteria: * pregnancy * history of renal dysfunction * use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid * hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure

Keywords: genital herpes viral shedding famciclovir symptomatic genital herpes asymptomatic genital herpes
prevalence of parenting style and child behavior

Conditions: Child Behavior; Parenting; Parent-Child Relations

Summary: prevalence of parenting style and assessment of child behavior and caries experience in relation to parenting style during first dental visit.

the success of dental visit depends on the child's behavior and cooperation which can be recognized from the child's first visit. child's behavior can be affected by the parenting style. there are four types of parenting styles: authoritative, authoritarian, permissive and neglecting, each affects the child in different ways. recently parenting styles became very interesting since parents are the primary caregivers and they have a great impact on the child's psychological and emotional development. however, every parent seeks for a rapid and easy treatment for their children, but if the child is uncooperative that will require multiple dental visits , more expenses or he/she might undergo general anesthesia which is more expensive. also, the parent-child relationship is very important ,bad relationship can cause insecurities, lack of self confidence and trust, resulting in the future a fearful and irresponsible man / woman.

Eligibility criteria:
inclusion criteria: * children with primary teeth * before the eruption of permanent molar * first dental visit * both genders exclusion criteria: * children with systemic diseases or congenital problems * parents refuse to participate

Keywords: parenting style child behavior first dental visit caries experience
aly688 ophthalmic solution in subjects with dry eye disease

Conditions: Dry Eye

Summary: study evaluating the safety and efficacy of two concentrations (0.4% and 1%) of aly688 ophthalmic solution in subjects with dry eye disease

randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of two concentrations (0.4% and 1%) of aly688 ophthalmic solution in subjects with dry eye disease

Eligibility criteria:
inclusion criteria: * dry eye disease for \> 3 months meeting specific sign and symptom criteria * best corrected visual acuity of +0.6 logmar or better * willing to sign informed consent and attend study visits * willing to comply with contraception requirements exclusion criteria: * unable to meet specific sign and symptom criteria * signs of ophthalmic allergic, inflammatory or infection conditions * use of contact lenses * anatomic abnormalities preventing accurate study assessments * use of medications that influence eye dryness * recent ophthalmic surgery * unwilling to suspend current treatments for dry eye disease
electromagnetic field on neck pain and proprioception in cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: purpose: to investigate effect of electromagnetic field therapy on neck pain and proprioception in cervical radiculopathy patients background: cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots pulsed electromagnetic field (pemf) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders

thirty four patients with cervical radiculopathy the patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. the evaluation methods by visual analogue scale for pain (vas-p), cervical joint position error test (jpet), neck disability index , and cervical range of motion (crom) goniometer device measurements

Eligibility criteria:
inclusion criteria: 1. age ranging from 30:45 2. cervical radiculopathy due to disc prolapse (c5-c6) (c6-c7) mild to moderate or disc prolapse according to magnetic resonance image (mri). 3. with mild to moderate cervical disability according to neck disability index 4. body mass index (18.5 to 29.9) kg/m2. exclusion criteria: 1. cervical myelopathy. 2. patients with previous cervical surgery. 3. inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis 4. any other musculoskeletal disorders of the spine or upper extremity.
predictors of rejection in pediatric kidney transplantation

Conditions: Rejection Acute Renal

Summary: renal transplantation is the best option among the end-stage renal disease (esrd) treatment alternatives, it is also relatively less expensive than dialysis. allograft rejection is a major issue in kidney transplantation. rejection is classified as acute or chronic, cellular or antibody-mediated.children with kidney transplants require life-long immunosuppressive therapy to prevent rejection of the allograft

the most common medication regimen in the united states includes the combination of corticosteroid (eg, prednisone), a calcineurin inhibitor (or cni, most commonly tacrolimus), and an antimetabolite such as mycophenolate mofetil (mmf). cyclosporine and azathioprine are less commonly used for maintenance immunosuppression tacrolimus level is a main maintenance immunosuppressant in kidney transplantation .in the early days of posttransplant period, hematocrit concentrations are generally low and increase significantly as patient recovers. because tacrolimus binds strongly to erythrocytes in systemic circulation, the effect of hematocrit on distribution of tacrolimus is important for the methods used to measure tacrolimus concentrations ,hematocrit correction could be a step towards improvement of tacrolimus dose individualization thearputic drug monitoring of mpa has been proposed to optimize drug dosage avoiding potential hematologic and digestive side effects .mpa monitoring is generally based on the determination of the plasma mpa trough concentration (c0) .

Eligibility criteria:
inclusion criteria: 1. paediatric living donor kidney transplant recipients (aged 1-18 years) 2. patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \[mycophenolate mofetil (mmf) and steroids 3. recipients with biopsy proven acute rejection in the studied group. exclusion criteria: 1. patients on cyclosporine 2. patients with active infection and dehydration 3. patients who received multiorgan transplantation non cooperative patient will be excluded
safety and effectiveness study with a new pda occluder for closure of patent ductus arteriosus

Conditions: Patent Ductus Arteriosus

Summary: the objective of the study is to investigate the safety, efficacy and clinical utility of the occlutech pda device for closure of patent ductus arteriosus of all types.


Eligibility criteria:
inclusion criteria: 1. patients with a demonstrated patent ductus arteriosus 2. female or male 3. belonging to any ethnic group 4. age between \> 6 months and 70 years 5. body weight \> 6 kg \< 120 kg exclusion criteria: 1. associated congenital cardiac anomalies, 2. body weight \< 6 kilograms general exclusion criteria * presence of a known coagulation disorder * thrombus at the position allocated for the implantation * a vein thrombosis in the blood vessels chosen for the introducing system * an active infection * nitinol intolerance (nickel or titanium) * contrast medium intolerance * patients who have a vascular system which is too small to admit the required sheath * patients with pulmonary hypertension and pulmonary-vascular resistance of \>8 woods units or a lung - / systemic resistance (pr/sr) of \>0.4.